Development and Validation of a Liquid Chromatography Method for the Analysis of Rivaroxaban and Determination of Its Production Related Impurities
- Authors: Arous B.1, Al-Mardini M.A.1, Karabet F.2, Daghestani M.2, Al-Lahham F.2, Al-Askar A.2
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Affiliations:
- Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University
- Department of Chemistry, Faculty of Sciences, Damascus University
- Issue: Vol 52, No 5 (2018)
- Pages: 483-490
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245263
- DOI: https://doi.org/10.1007/s11094-018-1844-z
- ID: 245263
Cite item
Abstract
The purpose of this work was to develop a sensitive and validated HPLC method for analysis of rivaroxaban and estimation of related impurities in parent drug substance and pharmaceutical dosage forms. The analysis was carried out on a Macherey-Nagel Nucleodur C18 column (250 × 4.6 mm, 5 μm particle size) with a mobile phase containing acetonitrile and water in gradient program at a flow rate of 1.5 mL/min, the column oven temperature 55°C, and the UV detector wavelength set at 254 nm. The method was validated according to USP38-NF33 guideline recommendations and to the ICH guidelines for validation. The linearity, selectivity, accuracy, precision, robustness, LOD and LOQ characteristics of the proposed method showed acceptable values. The method is suitable for practical routine analysis of drug substance and pharmaceutical dosage forms, and it was successfully used to analyze Rovaltro (Syrian product) and Xarelto (brand product). All the analysis results were acceptable according to pharmaceutical requirements.
Keywords
About the authors
Basima Arous
Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University
Author for correspondence.
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus
Mohammad Amer Al-Mardini
Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus
Francois Karabet
Department of Chemistry, Faculty of Sciences, Damascus University
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus
Manal Daghestani
Department of Chemistry, Faculty of Sciences, Damascus University
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus
Fida Al-Lahham
Department of Chemistry, Faculty of Sciences, Damascus University
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus
Alyamama Al-Askar
Department of Chemistry, Faculty of Sciences, Damascus University
Email: basima.arous@gmail.com
Syrian Arab Republic, Damascus